BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2081293 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-81213
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 502 MG/DL. THE CUSTOMER STATED THAT PRIOR TO THE EVENT, SHE HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS, AND THAT AFTER TWO INFUSION SET CHANGES, HER BLOOD GLUCOSE WAS STILL ELEVATING. THE DOCTOR STATED THAT THE INSULIN PUMP WAS THE CAUSE AS THERE WAS NO ALTERNATIVE EXPLANATION. THE CUSTOMER ALSO STATED THAT SHE USES A MODEL MMT-396 QUICK-SET INFUSION SET AND THAT SHE LAST CHANGED HER INFUSION SET THE DAY BEFORE THE EVENT. THE CUSTOMER THEN STATED THAT THE INSULIN MAY HAVE BEEN BAD. PROGRAMMING WAS CORRECT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED BOTH THE FIXED PRIME AND THE HIGH PRESSURE TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization UNOMEDICAL QUICK-SET INSULIN INFUSION SET:| MODEL MMT-396